
Paul E. Kalb, M.D.
Healthcare and FDA
Life Sciences
Food, Drug and Medical Device
In addition to his work on enforcement matters, Paul counsels private equity firms on life sciences investments and advises both boards of directors and companies on compliance issues. He is also a co-founder of the Medical Information Working Group, a coalition of life sciences companies dedicated to rationalizing the rules governing the exchange of scientific information.
Paul served on Sidley’s Executive Committee from 2007–2022 and, in that capacity, helped lead the firm’s strategic planning process. He co-founded Sidley’s Global Life Sciences practice, served as Global Practice Leader for the firm’s Healthcare and FDA Group from 2018–2022, and headed the firm’s Health Care Group from 2004–2018. He currently leads the firm’s Covid-19 Task Force and coordinates the firm’s healthcare and life sciences transactional initiatives.
Paul’s work representing clients has earned him acknowledgment in numerous industry publications. Naming Paul a “Health Care MVP,” Law360 noted that “his track record shimmers with borderline-historic achievements for life sciences clients” and that he “has repeatedly helped save the day when drugmakers faced steep fines and exclusion from government health programs.”
According to Chambers USA, from which he received a “Tier 1” ranking: “A J.D./M.D., Kalb is lauded for his tremendous, nuanced appreciation of critical enforcement matters.” Chambers also described him as “wickedly smart” and “widely acclaimed for his work representing device and drug manufacturers in government investigations,” and said that “when you bring him in and he’s talking, people listen.’” Chambers also described Paul as a “client-focused, results-oriented and pragmatic” lawyer; an “extremely good strategic thinker”; and a “strategist who is very analytical, very responsive, and easy to work with.”
Paul has received the highest ranking among U.S. lawyers in the “Government Enforcement and Investigations” category in PLC’s surveys of leading Life Science lawyers worldwide since 2006, and he has been recognized as a leading lawyer in PLC’s worldwide Dispute Resolution survey. He has been named by Super Lawyers magazine as one of the Top 100 lawyers in Washington based on a vote of peers; and he has been recognized by Washingtonian magazine as one of the “Top Lawyers in Washington” and by The Best Lawyers in America in Healthcare Law. Additionally, Paul was named a “Life Sciences Star” by LMG Life Sciences (2019–2022). Benchmark Litigation has honored Paul as a “Litigation Star” (2022–2023).
On five occasions, BTI Consulting, on the basis of a survey of general counsel of Fortune 1000 companies, has named Paul as a member of the BTI Client Service All-Star Team for law firms.
Paul is a graduate of Yale Law School, where he was a senior editor of the Yale Law Journal. Prior to attending law school, he received his M.D. degree, magna cum laude, from the Boston University School of Medicine where he was elected to the Alpha Omega Alpha Honor Medical Society. He completed his residency in Internal Medicine at the New York Hospital-Cornell Medical Center, and subsequently worked at both Memorial Sloan-Kettering Cancer Center and Yale-New Haven Hospital.
Paul has written numerous articles in legal, medical, and industry publications. He has focused, in particular, on the fiduciary obligations of directors to oversee “mission critical” risks. He speaks regularly at industry conferences and has also lectured on fraud and abuse issues at the Justice Department’s National Training Center. He was a visiting lecturer at Yale College in Medicine, Law, and Public Policy.
经验
- 代理事宜
- 会员资格与主要活动
Representative matters that are public include:
- Represented Millennium Pharmaceuticals in its successful defense of a qui tam action involving allegations of improper promotion of one of the company’s drugs
- Represented GE Healthcare in connection with an investigation of the company’s pricing and promotion of a radiopharmaceutical product
- Represented Bausch & Lomb in connection with a criminal investigation of ISTA Corporation, an acquired asset
- Represented Genentech in connection with criminal and civil investigations regarding Rituxan and Tarceva
- Represented DaVita in connection with an investigation of the company’s joint venturing practices and an investigation of its Healthcare Partners Medicare Advantage business
- Represented GlaxoSmithKline in Corporate Integrity Agreement negotiation
- Favorably resolved cases brought against Novo Nordisk regarding allegations of illegal promotional activity
- Defended Eli Lilly and Company in two investigations by federal and state prosecutors
相关业务能力
- Crisis Management and Strategic Response
- 食品、药品及医疗器械监管
- 全球生命科学
- Healthcare
- 生物科技
- Cell and Gene Therapy
- 临床实验
- 合规咨询-食品药物管理局
- 商业罪案合规咨询
- 虚假申报法案
- 美国《海外反腐败法》/反贿赂
- 食品药物管理局执行事宜
- 卫生保健报销
- 大陪审团调查
- 卫生保健执行
- 卫生保健欺诈
- 卫生保健诉讼
- Healthcare Payment, Delivery, and Management Services
- Healthcare Providers
- Healthcare Providers Crisis Management and Strategic Response
- 卫生保健公共政策与政府事务
- 卫生保健监管
- Healthcare Transactions
- 内部调查
- Life Sciences Transactions
- 医疗器械
- 医药
- Pre-Commercial Life Sciences Companies
- 上市公司
- 生命科学业务投资及并购风险评估和防范
- 风险缓解:美国市场销售
新闻与观点
证书
执业资格及证书
- U.S. Supreme Court
- U.S. Court of Appeals, 5th Circuit
- U.S. Court of Appeals, 8th Circuit
- U.S. Court of Appeals, 9th Circuit
- U.S. Court of Appeals, 10th Circuit
- U.S. Court of Appeals, 11th Circuit
- U.S. Court of Appeals, D.C. Circuit
- 美国联邦巡回上诉法院
- U.S. District Court, District of Columbia
- 美国华府哥伦比亚特区
- 美国纽约州
学历和教育
- Yale Law School, 法学博士, 1990
- Boston University School of Medicine, M.D., 1983 (magna cum laude, Alpha Omega Alpha)
- Boston University, 文学学士, 1979 (summa cum laude, Phi Beta Kappa)